生物类似阿达木单抗治疗 Behçet 葡萄膜炎的疗效。
Efficacy of Biosimilar Adalimumab in the Treatment of Behçet's Uveitis.
机构信息
Ophthalmology Department and Ophthalmic Research Center, Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Science, Tehran, Iran.
出版信息
Ocul Immunol Inflamm. 2022 Aug;30(6):1495-1500. doi: 10.1080/09273948.2021.1900276. Epub 2021 Apr 7.
PURPOSE
This study aimed to evaluate biosimilar adalimumab's efficacy and safety in patients with Behçet's uveitis in Iran.
METHODS
We performed a study on patients who mostly (79.2%) had a failure on conventional treatment with the mean follow-up time of 19.24 months (95% confidence interval (CI), 16.52-21.96). All the enrolled patients were anti-tumor necrosis factor (anti-TNF) naiive. The primary endpoint was best-corrected visual acuity (BCVA) improvement, and the secondary endpoints were changes in macular thickness, vitreous haze grade, anterior chamber (AC) cell grade, prednisolone dose, and the incidence of adverse reactions.
RESULTS
Forty-eight patients were enrolled in the study. After adalimumab use, visual acuity improved significantly (-value˂.001); vitreous haze grade decreased (-value˂.001), and AC cell grade improved (-value = .002). Macular thickness decreased, but its change was not statistically significant (-value = .1). Moreover, adalimumab showed a corticosteroid-sparing effect (-value = .03).
CONCLUSION
Biosimilar adalimumab (CinnoRA®) is effective and well-tolerated in Behçet's uveitis.
目的
本研究旨在评估在伊朗，阿达木单抗生物类似药治疗贝赫切特葡萄膜炎患者的疗效和安全性。
方法
我们对主要（79.2%）经传统治疗失败的患者进行了研究，平均随访时间为 19.24 个月（95%置信区间（CI）：16.52-21.96）。所有入组患者均为抗肿瘤坏死因子（anti-TNF）初治患者。主要终点是最佳矫正视力（BCVA）的改善，次要终点是黄斑厚度、玻璃体内混浊程度、前房细胞分级、泼尼松剂量和不良反应的发生率的变化。
结果
本研究共纳入 48 例患者。阿达木单抗使用后，视力明显提高（-值<.001）；玻璃体内混浊程度降低（-值<.001），前房细胞分级改善（-值=0.002）。黄斑厚度虽有降低，但差异无统计学意义（-值=0.1）。此外，阿达木单抗具有激素节省效应（-值=0.03）。
结论
贝赫切特葡萄膜炎患者使用阿达木单抗生物类似药（CinnoRA®）疗效确切，安全性良好。
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